KR101545765B1

KR101545765B1 - Implantable Access Port Device and Attachment System

Info

Publication number: KR101545765B1
Application number: KR1020107025702A
Authority: KR
Inventors: 이튼 프랭클린; 자넬 에이. 버크
Original assignee: 알러간, 인코포레이티드
Priority date: 2008-04-17
Filing date: 2009-04-17
Publication date: 2015-08-20
Also published as: ZA201007359B; EP2300095B1; EP2471572A3; EP2471573B1; ES2537815T3; US8398654B2; US20090264901A1; AU2009236055A1; CA2721309C; EP2471573A3; NZ588818A; MX2010011367A; US9023062B2; KR20110006686A; RU2010146064A; US20110213199A1; EP2300095A1; CN102099078A; EP2471573A2; AU2009236055B2

Abstract

A system for attaching an access port to body tissue includes an access port assembly including an access port having a generally central (52) axis. The access port assembly further includes an attachment mechanism having a structure capable of attaching the access port to, for example, the abdominal muscle of the patient. The transport tool 30 includes a handle 90 having a generally vertical axis 92 and a transport head 96 having a structure that engages the access port assembly and is configured such that when the transport head is so engaged with the access port assembly, And an activation mechanism 98 for enabling deployment of the mechanism. The transport tool is configured such that the longitudinal axis of the handle is spaced from the alternative center axis of the access port when the transport head is so engaged with the access port assembly.

Description

TECHNICAL FIELD [0001] The present invention relates to an access port device and an attachment system,

This application claims the benefit of U.S. Provisional Patent Application No. 61 / 045,890, filed April 17, 2008, the entire disclosure of which is incorporated herein by reference.

The present invention relates generally to medical implants, and more particularly to implantable access port devices and attachment mechanisms for attaching such access port devices to tissue.

Medical implants for performing a therapeutic function on a patient are well known. Such devices include a pacemaker, a vascular access port, an infusion port (e.g., used in a gastric banding system), and a gastric pacing device. Such implants need to be attached to the appropriate site, typically subcutaneously, in order to function properly. It is desirable that the procedure of transplanting such a device is fast, easy and efficient and requires as little ablation as possible.

The invention may be better understood with reference to the following detailed description and drawings. here:
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic perspective view of an access port assembly of a system of the present invention when implanted in a patient and used to inflate and deflate a conventional wristband for the treatment of obesity;
Figures 2 and 3 are perspective views of a conventional wristband useful in conjunction with the system of the present invention, in which the wrist band is shown in its contracted state and in its expanded state;
4 is a perspective view of a system in accordance with the present invention including an access port assembly and a transport tool for applying the access port assembly to body tissue;
Figure 5 is a perspective view of the transport head of the tool spaced from the access port assembly and access port assembly of the system shown in Figure 4;
Figure 6 is an exploded view of the access port assembly shown in Figure 5;
6A is a cross-sectional view of an access port assembly coupled with a transport head;
Figure 7 is a partial cross-sectional side view of the system shown in Figure 4;
Figures 8A and 8B are cross-sectional side views of a proximal portion of the tool, respectively, illustrating the unlocked and locked state activation mechanisms;
Figure 9 is a side view of the distal end of the tool;
10 is a cross-sectional view of the distal end of the access assembly and tool of the system of the present invention;
Figs. 11, 12 and 13 are cut-away views of an access port having an anchor in a non-deployed state, a partially deployed state and a fully deployed state, respectively,
Figure 14 is a cross-sectional view of the top of the tool taken along line 14-14 of Figure 12;
15 is a cross-sectional view taken along line 15-15 of FIG. 13;
Figure 16 is a cross-sectional view taken along line 16-16 of Figure 14;
17 is a cross-sectional view taken along line 17-17 of Fig.

Summary of the Invention

The present invention is directed to a system comprising an implantable access port, for example, but not limited to, an implantable access port for use in inflating and deflating an expandable gastric band. Generally, the system includes an access port configured to be connected to the inflatable portion of the band by, for example, a fluid conduit. Access ports for use with the above bands are well known and include, for example, U.S. Patent Application No. 10 / 562,964, filed September 15, 2004; U.S. Patent Application No. 10 / 562,954, filed January 21, 2005, U.S. Patent Application No. 11 / 472,902, filed June 22, 2006, U.S. Patent Application No. 11 / 444,702, and U.S. Patent Application No. 11 / 540,177, filed September 29, 2006, the entire disclosures of each of which are incorporated herein by reference.

In one aspect of the present invention, a system for attaching an access port to body tissue is provided.

The system generally includes an access port assembly including an access port and generally an access port housing including an access port. The access port may be a structure for holding, receiving, and allowing passage of fluid between the access port assembly and the patient or other implanted device in the patient, e.g., a gastric band. have.

For example, the access port includes a bottom, side wall, and needle penetratable septum. The needle penetrable diaphragm is spaced from the bottom and lies in a plane approximately parallel to it. The sidewalls, bottom and diaphragm define a space for holding the fluid. The access port assembly generally has a central axis extending through the floor, diaphragm, and space for fluid retention. The sidewall generally surrounds the axis and is radially spaced therefrom.

The access port assembly further includes an attachment mechanism including a plurality of rotatable anchors having, for example, a deployed position and an undeployed position. In the deployed position, the anchor secures the access port to the body tissue. When a system associated with the band is used, the access port assembly may be secured to the rectus muscle fascia by an anchor.

In some embodiments, the attachment mechanism is reversible so that the implantable medical device can be detached from the tissue.

In certain embodiments, each of the anchors is made of a bent, stainless steel wire having a multi-faceted, sharp distal tip of wire, e.g., a circular cross-section and multiple faces.

In an embodiment, the plurality of anchors includes four anchors spaced apart from the access port. Each anchor includes a curved distal portion that captures tissue and a pivotal proximal portion that is rotatably connected to the access port housing. In some embodiments, the proximal portion of the pivotal type is substantially perpendicular to the curved distal portion, and more specifically, substantially perpendicular to the plane at which the curved distal portion rotates as the anchor moves to the deployed position. In some embodiments, each anchor may include a generally linearly proximal portion that is generally perpendicular to the spiral end portion and the helical distal portion. For example, during rotation of the rotatable actuator of the access port housing, a cam system may be used as a means for driving the deployment of the anchor.

In another aspect of the present invention, the system further comprises a delivery tool having a structure that facilitates attachment of the access port assembly to body tissue. The tool includes a handle having a generally longitudinal axis and a distal end having a structure coupled to or engaged with the access port assembly. The tool further includes an activation mechanism for activating deployment of the attachment mechanism. In some embodiments, the tool is configured such that the generally vertical axis of the handle is spaced from the generally central axis of the access port when the shipping tool engages the access port assembly. For example, the delivery head of the tool is offset from the tool handle. For example, the tool generally has a non-linear, or curvilinear, configuration with a transport head located on the front of the handle or extending away from the handle.

In another aspect of the invention, the activation mechanism of the tool includes a cable mechanism, e.g., two cables extending from the proximal end of the tool to the transport head along the tool handle. In certain embodiments, the cable mechanism includes two oppositely moving cables. The longitudinal movement of the cable mechanism as the tool engages the access port assembly causes rotational movement of the anchor. The cable may be made of tungsten or tungsten material. Generally, each cable includes a substantially straight proximal portion extending along the handle of the tool and a curved distal portion connected to the rotational elements of the transport head.

Each and every feature, and each and every combination of two or more such features described herein, is included in the scope of the present invention unless the features included in such combination conflict with each other.

details

Referring to Figure 1, a simplified perspective view of an access port assembly 10 of a system of the present invention is shown. The access port assembly 10 is shown when it is infiltrated by the needle 2 of the manually operable syringe 3. The needle 2 and the syringe 3 may be inserted into the accessory port assembly 10 by a conventional upper band 4, as described below in more detail, by drawing fluid into the access port assembly 10, Or contraction of the stomach of the stomach (5) of the stomach (5), thereby providing a convenient means of controlling the size or limiting level of stoma of the patient's stomach (5). The upper band 3 is shown in a contracted state in Fig. 2 and is shown in an expanded state in Fig. 3, and is not considered to constitute an embodiment of the present invention.

Referring to FIG. 4, a system 20 according to an embodiment of the present invention is shown. The system 20 generally includes an implantable access port assembly 10 and a tool 30 for securing the access port assembly 10 to body tissue. The access port assembly 10 is configured to be connected to the inflatable portion of the upper band 4, for example, by a fluid line 6 (see FIG. 1).

5, access port assembly 10 generally includes an access (not shown) having a diaphragm 36, a chamber 37 (shown in FIG. 6A), and an inlet / Port 34 as shown in FIG. The access port 43 has a structure for holding, receiving, and allowing passage of fluid between the inlet / outlet connector 38 and the fluid line 6.

In the illustrated embodiment, if the use of the tool 30 for attaching the access port assembly 10 is not desired, the access port assembly 10 may include accommodation to facilitate suturing the patient . For example, a suture hole 40 is provided. A needle clearance region 41 may also be provided to facilitate suturing.

The access port assembly 10 is shown in detail in Figures 6 and 6A. The access port 34 includes an access port bottom 42, a substantially cylindrical access port side wall 44, and a needle penetrable diaphragm 36. The access port 34 includes a passage extending from the chamber 37, e.g., an outlet barb 48, which forms part of the inlet / outlet connector 38 that is coupleable to the fluid line 6 .

Kinking, rotating (rotating) the fluid line 6 when the line 6 is connected to the access port assembly 10, and is locked within the coupler 51 of the housing side wall 56, a strain relief element 50 may be included in the inlet / outlet connector 38 to protect it from rotating or torquing. Additional strain relief may be provided by the flexible sleeve 51a. The flexible sleeve 51a can be made of a puncture-resistant material and along the strain relief element 50 provides protection against unintentional needle piercing on the line 6. [

The diaphragm 36 is spaced from the access port bottom 42 and lies in a plane approximately parallel thereto. The diaphragm 36 may be made of any suitable needle penetrable material, for example, a self-sealing, needle penetrable material. Access port sidewall 44, access port bottom 42 and diaphragm 36 define a chamber 37, or space, for holding fluid. The access port bottom 42 and access port side walls 44 may be integral components of a substantially single structure made of a biocompatible metallic material, for example, titanium. The outlet bar 48 may also be made of the same material.

The access port assembly 10 generally has a central axis indicated by line 52 in Figure 6 extending through the access port bottom 42, the diaphragm 36 and the chamber 37. Generally, the access port side wall 44 surrounds and is radially spaced from the alternative center axis 52. When the access port assembly 10 is implanted for use in a patient, the alternative center axis 52 is generally perpendicular to the surface of the tissue or muscle to which the access port assembly is attached.

The access port assembly 10 further includes a housing 54 that includes a housing side wall 56 that substantially surrounds the access port side wall 44, and an actuator assembly.

The actuator assembly is comprised of an actuator cap 58 and an actuator element 62 rotatable relative to the housing side wall 56 (as indicated by arrow 64 on the actuator cap and actuator element 62). The housing 54 further includes an anchor base 66 that includes a track 68 for receiving an actuator element 62.

The access port assembly 10 further includes an attachment mechanism 70. Attachment mechanism 70 has a structure for anchoring or securing access port assembly 10 to a patient. The attachment mechanism 70 may include, for example, a plurality of rotatable anchors 74 movable between a non-deployed position and an unlatched position.

In the illustrated embodiment, the plurality of rotatable anchors 74 include four anchors 74. In general, the anchors 74 are spaced about the circumference of the access port 34 and are spaced, for example, substantially equidistant. When in the open position, the anchor 74 is substantially concealed and is contained between the actuator element 62 and the housing side wall 56. During deployment, the anchor 74 rotates and slides through the hole 75 in the anchor base 66 to move from the substantially concealed position in which it was received to the exposure position.

Each anchor 74 can be made of wire, for example, stainless steel wire. The anchor 74 may include a bent wire having a generally circular cross-section and a sharp distal tip 76.

The anchor tip 76 has a structure that penetrates into the body tissue when the anchor 74 rotates to the deployed position. In some embodiments, the anchor tip 76 includes one or more flat faces. For example, tip 76 may have a single side, or may be multiple side. For example, tip 76 may have two sides or three or more sides.

In a particular embodiment, the anchor 74 is a bent stainless steel wire and generally has an arc shape with an arc diameter of less than about 0.5 inches and a constant circular cross section of about 0.023 inches in diameter.

Each anchor 74 includes a curved distal portion 80 that captures tissue and a pivotally proximal portion 82 that is pivotally connected to anchor base 66 of the port housing. In the embodiment shown, the pivotal proximal portion 82 is substantially perpendicular to the curved or spiral distal portion 80, or more specifically, when the anchor 74 rotates to the deployed position, Is substantially perpendicular to the plane of travel.

Referring briefly to FIG. 4, the access port assembly 10 further includes a removable safety cap 83 for protecting the physician or medical staff's hands and fingers from unintentional piercing. The safety cap 83 is mounted on the bottom of the access port housing 54 by a press-on fit. The color of the safety cap 83 can be easily distinguished from the port housing color.

6, access port assembly 10 includes one or more locator elements 84, e.g., at least one or two or more radio-opaque labels that can be clearly seen under X- opaque marker 86). These are fixed to the port housing 54 and can be spaced from the access port 34 so that the cover image is not hidden by the image of the access port 34. [ In a particular embodiment, two indicia 86 are provided, each dimension having a length of about .075 "X .200" and a spacing distance from the access port 34 of at least about 0.100 " May be used to facilitate identification of the type of banding or other useful information, e.g., identified by the X-ray image of the access port assembly 10, using various arrangements of the indicia 86 .

7, the tool 30 includes a handle (not shown) having a generally vertical axis (indicated by line 92) and a distal end 96 having a structure removably and functionally coupled to the access port assembly 10 90).

The tool 30 is configured such that the generally vertical axis of the handle 90 extends from the generally central axis 52 of the access port 34 when the tool 30 is coupled with the access port assembly 10. [ Spaced apart, or not in alignment with it. In other words, the transport head 96 of the tool 30 engaging the access port assembly 10 is offset from the tool handle 90, i.e., the portion of the tool 30 that is handled by the operator. In some embodiments, the generally central axis of the access port 34 and the longitudinal axis of the handle are offset from about 1 inch to about 2 inches or more in spacing.

For example, the tool 30 can be a generally curved, scoop-shaped, L-shaped, or similar "shaped " shape, with the transport head 96 positioned forwardly or away from the handle 90. [ Offset "shape. Because of this configuration, the tool 30 may be, for example, in a substantially straight line configuration or a conventional applier that requires a tool that is substantially completely in line with the center axis of the access port of similar size during surgical implantation ) Or using a relatively small incision as compared to a tool, to implant the access port assembly 10. During implantation of the access port assembly 10, the physician inserts the transfer head 96 into the incision, which is somewhat offset from the implant site, i.e., the target site where the access port is attached.

Referring also to Figs. 8A and 8B, the tool 30 includes an activation mechanism 98. Fig. The activation mechanism 98 enables automatic deployment of the attachment mechanism 70, for example, by a physician using the system 10 to attach the access port assembly 10 to the patient. The activation mechanism 98 will be described in greater detail elsewhere herein.

9 shows a side view of the transport head 96 of the tool 30. Fig. The transport head 96 includes an upper portion 100 and a side wall 101. When the tool 30 is coupled with the access port assembly 10, the upper portion 100 extends over at least a portion of the access port 34 and the actuator cap 58 (see FIG. 5) Extends around at least a portion of the sidewall 56 and is clipped thereto.

Referring again to Figures 8A and 8B, in this exemplary embodiment, the activation mechanism 98 includes a cable mechanism 102 that is coupled to a trigger mechanism 104.

The cable mechanism 102 includes two oppositely moving cables 106 made of tungsten or similar material. The cable 106 extends from the trigger mechanism 104 along the tool handle 90 to the transfer head 96 of the tool 30. The trigger mechanism 104 includes a manually compressible trigger 104a and a trigger release button 104b.

Generally, each cable 106 includes a substantially straight proximal portion extending along the handle of the tool 30 and a curved distal portion connected to the rotational element 108 of the transport head 96 Reference). A suitable structure, for example, a cable anchor 107, is provided for securing the cable 106 in place. As the wheel 132 rotates, the cables 106 move in opposite directions.

To deploy the staple 74, the operator presses the trigger 104a as shown in Figure 8A. Pressing the trigger 104 compresses the spring 130, causing the wheel 132 to rotate and the cable 106 to move vertically. Trigger latch 134 is biased with respect to wheel 132, for example, by a spring (not shown). If the trigger 104a is fully depressed as shown in Fig. 8B, the trigger latch 134 will move from the detent notch 132a (the stop notch 132 is seen more clearly in Fig. 8A) And locks the trigger mechanism 104. When the trigger 104a is fully depressed, the trigger release button 104b is "out" as shown in Fig. 8B. The operator presses the trigger release button 104b so that the trigger latch 134 is released from the stop notch 132a and the load of the spring 130 is applied to the wheel 132 Causing a reverse rotation.

5 and 6, the longitudinal movement of the cable 106, activated by manually pressing the trigger 104a, causes the rotation of the rotary element 108 and the reciprocal rotation of the actuator cap 58 ).

Rotation of the actuator element 62 causes rotation of each anchor 74.

Figs. 11, 12 and 13 illustrate the deployment of an anchor 74 from a non-deployed position, each retracted back, through a deployed, deployed position to an actuated position.

Referring now to Figures 5 and 10, the distal end of the tool 30 is coupled to the access port assembly 10 by inserting the access port assembly 10 between the side walls 101 of the distal end 30. As the tool 30 engages the access port assembly 10 the projection 112 of the rotary element 108 is secured to the receiving port 114 of the actuator cap 58 and the clips 116 of the distal side wall 101 Is engaged with an undercut 118 of the housing side wall 56. As shown in Fig.

Referring briefly to FIGS. 11, 12, and 13, a partial cross-sectional view is shown when the access port assembly 10 is stapled and secured to an abdominal muscle fascia 120. FIG.

11-17 illustrate different views of the access port assembly 10 and the transport head 96 during anchor deployment.

More specifically, FIG. 11 shows an attachment mechanism 70 prior to deployment of the anchor 74.

12, 14 and 16 illustrate the transport head 96 and the access assembly 10 during deployment of the anchor 74. 16, the clips 116 of the transport head 96 are securely fastened to the undercuts 118 of the housing side walls 56 during deployment and before fully deployed.

13, 15, and 17, when the activation mechanism 98 is fully deployed, the structure, e.g., the berm 142, of the rotating element 108 moves the clip 116 outwardly Thereby releasing the engagement with the undercut 118, thereby releasing the access port assembly 10 from the transport head 96.

Example

System Usage

The following example illustrates a manner of using the system 20 of the present invention shown and described herein for attaching the access port assembly 10 to a gastric banding patient.

Referring generally to the drawings, the physician threaded the softening tubing 50 over the soft tubing 6 leaving about 2 cm of tubing extending beyond the locking end of the strain relief element 50 thread.

The tubing is then coupled to the barb 48 to a flush having a housing side wall 66 of the port housing 54. Then, the strain relief element 50 is pressed and locked to the coupler 51.

The physician verifies that the trigger mechanism 104 is in the fully open position, as shown in FIG.

The doctor places the access port assembly 10 on the table so that the safety cap 83 contacts the table (Figure 4) and moves the transfer head 96 to the access port assembly 10 in the direction along the axis 52 of Figure 7 And inserts the access port assembly 10 into the transport head 96 of the tool 30. This causes the access port assembly 10 to snap into the transport head 96. Then, the safety cap 83 is removed from the access port assembly 10 by hand. At this time, the anchor 74 is in the position as shown in Fig.

The doctor places the tubing from the upper band into the abdomen. The access port assembly 10 is located on the side of the trocar opening and a pocket for the access port assembly 10 is created to be located sufficiently far from the trocar path to avoid unexpected twist of the tubing. The tubing path is positioned so that the tubing forms a straight line with gentle arching transitions into the abdomen. The tubing is positioned perpendicular to the patient ' s midline.

Your doctor will check if the fat is completely removed and you can see the rectus femoris. The access port assembly 10 inserts the transfer head 96 of the coupled tool 30 into an incised pocket at an angle to facilitate insertion. The access port assembly 10 is placed flat against the fascia so that all of the anchors 74 securely grasp the fascia and / or muscle tissue. The doctor applies finger pressure to the upper portion 100 of the transport head 96 to ensure that the access port assembly 10 is flat against the fascia and does not move the tool 30 for firing.

The physician tightly holds the trigger mechanism 104 until the trigger mechanism 104 is fully closed thereby causing the anchor 74 to deploy into the underlying fascia. At this time, the activation mechanism 98 is locked to the closed position as shown in Fig. 8B and the anchor 74 is fully deployed, as shown in Figs. 13, 15 and 17.

To isolate the tool 30 from the access port assembly 10, the physician slides the transport head 96 away from the access port assembly 10, for example, horizontally or laterally, Lift from the site. The doctor sweeps around the base of the access port assembly with his fingers to ensure that the anchor 74 is fully secured within the fascia.

When the access port assembly 10 is relocated away from the fascia, the trigger release button is depressed to release the trigger mechanism 104 from the position shown in FIG. 8B by releasing the latch mechanism. When the trigger is fully opened, the stainless steel anchor will completely retract back into the access port assembly 10 again. The tool 30 can then be used to deploy the access port assembly 10 back to a different, e.g., more desirable location, as described above.

A number of advantages gained by using the concept of the present invention have been described. One or more of the above description of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the particular forms disclosed. Modifications or variations are possible in light of the above teachings and are considered to be within the scope of the present invention. One or more embodiments have been chosen and described in order to illustrate the principles of the invention and its practical application, thereby enabling one of ordinary skill in the art to use the invention with various modifications as are suited to the particular use contemplated for the various embodiments.

Claims

A system for attaching an access port to a body tissue,
An access port having a central axis and including a bottom, a sidewall and a needle penetrable diaphragm,
Comprising an attachment mechanism having a structure that allows an access port to be attached to body tissue
Access port assembly;
A handle having a longitudinal axis,
A transport head having a structure for engaging with the access port assembly,
And an activation mechanism for enabling deployment of the attachment mechanism when the transfer head is so engaged with the access port assembly
Includes transportation tools;
Wherein the transport tool is configured such that the longitudinal axis of the handle is spaced from the central axis of the access port when the transport head engages the access port assembly in such a way.

2. The system of claim 1, wherein the bottom of the access port is integral with the access port side wall.

3. The system of claim 2, wherein the access port side walls and access port bottoms are unitary configurations.

4. The system of claim 3, wherein the access port side wall and access port bottom are titanium.

3. The system of claim 2, wherein the access port assembly further comprises a housing including a housing side wall surrounding the access port side wall, and an actuator assembly rotatable relative to the housing side wall.

2. The system of claim 1, wherein the activation mechanism of the tool comprises a cable mechanism.

7. The system of claim 6, wherein the cable mechanism comprises a cable comprising a tungsten material.

7. The system of claim 6, wherein the cable mechanism comprises a cable extending along the handle to the transport head.

The system of claim 6, wherein longitudinal movement of the cable mechanism causes rotational movement of the attachment mechanism as the transport head engages the access port assembly.

9. The system of claim 8, wherein the cable comprises a linear, proximal and curvilinear end.

The system of claim 1, wherein the attachment mechanism comprises at least one wire anchor.

12. The system of claim 11, wherein the wire anchor comprises a curved wire having multiple surface tips.

2. The system of claim 1, wherein the attachment mechanism comprises at least one anchor having a curved distal end and a pivotal proximal perpendicular to the curved distal end.

2. The system of claim 1, wherein the attachment mechanism comprises at least one anchor having a spiral end and a linear, proximal end perpendicular to the spiral end.

13. A shipping tool for attaching an access port assembly to a body tissue, the access port assembly comprising a deployable fastener and access port and a central axis,
A handle having a longitudinal axis,
A transfer head having a structure engaging an access port assembly having a deployable fastener, the transfer head at the distal end of the handle,
And an activation mechanism to enable deployment of the fastener when the transfer head is so engaged with the access port assembly;
The shipping tool is configured such that the longitudinal axis of the handle is spaced from the central axis of the access port when the shipping tool is engaged with the access port assembly;
The activation mechanism of the tool includes a cable mechanism;
The cable mechanism includes a cable extending along the handle to the transport head,
The longitudinal movement of the cable mechanism causing rotational motion of the attachment mechanism when the transport head is so engaged with the access port assembly;
A cable comprising a straight, proximal and a curved distal end.

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